FDA grants 510(k) clearance to Alere’s reader platform and BinaxNOW card 2

12 April 2017 (Last Updated April 12th, 2017 18:30)

The US Food and Drug Administration (FDA) has granted 510(k) clearance for the commercialisation of Alere's diagnostic analyser 'Alere Reader' and its BinaxNOW Influenza A & B Card 2.

The US Food and Drug Administration (FDA) has granted 510(k) clearance for the commercialisation of Alere's diagnostic analyser 'Alere Reader' and its BinaxNOW Influenza A & B Card 2.

Alere Reader will be initially used with the BinaxNOW Influenza A & B Card 2, which is a reformulated antigen influenza test, and will be later extended to other lateral flow applications and assays.

The reader is capable of analysing objective results and connectivities that are considered useful for the assessment of several formats of lateral flow immunoassays.

When a test card is inserted, the reader detects, identifies and analyses the completed lateral flow assay, with results shown on a touchscreen.

Results can be linked to the electronic medical records of the patients, back-end information systems, or printed.

"The Alere Reader platform, paired with Alere’s market-leading lateral flow portfolio, will ensure that over time this novel technology will be accessible for use with a wide variety of diseases and conditions across numerous clinical settings."

Alere Infectious Disease global president Avi Pelossof said: "The Alere BinaxNOW Influenza A & B Card 2 test, with the Alere Reader, improves what is already a leading rapid testing solution for influenza diagnosis in two key ways: by eliminating operator subjectivity and by connecting test results with information management systems.

“The Alere Reader platform, paired with Alere’s market-leading lateral flow portfolio, will ensure that over time this novel technology will be accessible for use with a wide variety of diseases and conditions across numerous clinical settings."

It is expected that Alere Reader can be used to achieve precise results in a significant timeframe, leading to the rapid administration of treatment.

The reader secured in-vitro diagnostic (IVD) CE Marking in August last year and was later launched in European and Asian markets.